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Completed

NCT Number: NCT04540198

GamePlan4Care: Online Support for Family Caregivers

As the population of older adults grows, almost doubling in size from 2012 to 2040, so too will the need for family caregiving. Caregiving can lead to negative psychosocial outcomes such as depression, anxiety, and burden; social isolation and family conflict: financial strain due to costs of care; and some caregivers also experience negative health consequences. This project will test the value of GamePlan4Care (GP4C) an evidence-based, internet-enabled system capable of providing immediate, tailored education and skills training to caregivers who can access live support from a DCS via phone or web-based video.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alzheimer's Texas

Austin, Texas, 78731, United States

About this study

Daily care and supervision of a person living with dementia (PWD) has been defined as "intense caregiving" and is associated with significant daily burdens and an overall threat to the caregiver's quality of life. Despite evidence suggesting that negative consequence can be remediated with community-based supports, those services remain allusive to caregivers due to the systemic challenges of turning interventions into services. This study is based on a practical approach of applying technology to an existing evidence-based intervention, Resources for Enhancing Alzheimer's Caregiver Health II (REACH II), refined with real-world user feedback and rigorously tested with the goal of creating an online family caregiver support system that has the potential of both scalability and sustainability. This two-group randomized controlled trial will compare the relative impact of GP4C to an education-based online site called Resources4Care (R4C) on a wide range of family caregiver outcomes. Family caregivers will be randomized to one of the two conditions and will complete an assessment battery at baseline and at the 6-month follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be age 18 years or older
  • Providing at least 8 hours of weekly care and/or supervision (on average) for a friend or family member with a self-reported diagnosis of Alzheimer's disease or a related dementia. Family will be subjectively determined by the caregiver to enable a broader definition of a" "family" member often found in minority communities (e.g., a person not related by blood but who serves in the role of an "aunt" or "grandchild").
  • The family member, named as the care recipient (CR) in this proposal, must be diagnosed with AD/ADRD (self-report from the caregiver accepted) and is experiencing signs of dementia as verified by the family caregiver on the AD8 informant interview. A score of 2 or greater is the inclusion criteria.
  • Must demonstrate access to a home computer with internet access to research staff and report using the computer to access the internet at least three times per week, on average.
  • English-speaking caregivers
  • Must reside within the recruitment area (Target counties within Texas: Bastrop, Bell, Blanco, Burnet, Caldwell, Coryell, Fayette, Hamilton, Hays, Lampasas, Lee, Llano, Milam, Mills, San Saba, Travis, Williamson)

Exclusion criteria

  • Current participation in another caregiving evidence-based program
  • Previous participation in usability testing for current system development

Treatment and study plan

GamePlan4Care

Behavioral

GamePlan4Care; Experimental

Resources4Care

Behavioral

R4C; Active Comparator

Primary outcomes

  1. Change From Baseline Caregiving Burden at 6 Months

    Time frame: Baseline and six months

    A 12-item version of the Zarit Caregiver Burden Interview. The Zarit Caregiver Burden Interview (ZBI) is an assessment tool for evaluating caregiver burden. The ZBI consists of 12 items representing a statement related to some aspect of perceived burden. Respondents (i.e., caregivers) rate each item ranging 0 (=never) to 4 (=nearly always). Total ZBI score is the summation of 12 items ranging from 0 to 48. Higher scores indicate greater burden.

  2. Change From Baseline Depression at 6 Months

    Time frame: Baseline and six months

    Levels of depressed symptoms:

    A 10-item Center for Epidemiological Studies Depression Scale (CES-D) is scored from zero (= rarely or none of the time) to three (= most or all of the time). Two items are reverse scored. The total score ranges from zero to 30 indicating that higher scores are higher levels of depressive symptoms.

  3. Change From Baseline Social Support at 6 Months

    Time frame: Baseline and six months

    Assessment of availability of support and satisfaction with support from others:

    Two subscales of the Social Provisions Scale (SPS), Reliable Alliance and Guidance, assessed the availability of social support and satisfaction with support received from others. Each subscale has four items. Each question is scored from one (=strongly disagree) to four (=strongly agree). Each subscale contains two questions that are reverse-scored. Ranging from four to 16, the higher total scores indicate higher levels of reliable alliance and guidance.

Secondary outcomes

  1. Change From Baseline Caregiver Stress at 6 Months

    Time frame: Baseline and six months

    Assessment of levels of stress:

    Perceived Stress Scale (PSS) was used to assess the degree of stress individuals experienced, using 10 items. Each item is scored from zero to four, with a total score range of zero to 40. Four items were scored reversely. Higher total scores indicate greater perceived stress.

  2. Change From Baseline Reported Positive Aspects of Caregiving at 6 Months

    Time frame: Baseline and six months

    Assessment of favorable aspects of caregiving experiences:

    The PAC was measured with 11 items of the favorable aspects of caregiving experience. Each question is scored from zero to four with a total score ranging from zero to 44. Higher scores indicate higher levels of positive feelings from caregiving.

  3. Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months

    Time frame: At Baseline and 6 months

    Presence and severity of neuropsychiatric symptoms and levels of relevant caregiving distress :

    The NPI-Q measures the presence, severity and distress ratings of 12 neuropsychiatric symptoms in patients with dementia. Presence of each symptom and distress ratings for each symptom are reported as well as the total sum of dementia behaviors and distress scores for each symptom. Each dementia behavior was scored as a binary change score (yes/no). Distress is scored from zero to five with higher scores indicating higher levels of distress.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

GamePlan4Care: Web-based Delivery System for REACH II

Acronym: GP4C

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 7, 2020
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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